LMS e-Learning Implementation Series Customer Interview: Advanced Bio Healing
Training for an FDA Regulated Manufacturing Company
SyberWorks: Welcome to the next edition of the SyberWorks LMS e-Learning Implementation Interview Series, where we look at actual learning management system implementations and e-learning program roll-outs.
SyberWorks specializes in custom e-learning solutions and learning management systems for corporations, governments, and non-profits. In this edition we are talking with Fran Schnack, project director for Advanced Bio Healing, Inc. about their use of the SyberWorks Learning Management System to train and manage compliance training for their medical manufacturing employees.
SyberWorks: And now let’s meet with Fran Schnack, project leader for Advanced Bio Healing, Inc. Good morning Fran. Thanks for coming to talk with us today.
Fran Schnack: Hi. Nice talking to you too.
SyberWorks: Fran, tell us about yourself and what you do for Advanced Bio Healing, Inc.
Fran: Well I am in the IT department and I manage the software systems for the company. In that role I am pretty much responsible for all the implementation and maintenance and integration of software systems.
SyberWorks: I understand that Advanced Bio Healing is a bioengineering firm. But can you tell us a little more about your company and the products they make?
Fran: We make a product called Dermograft. It is a skin which we produce and grow in our manufacturing plant here in La Jolla from the cells of newborn foreskin.
Dermagraft is indicated for the use in treatment of diabetic foot ulcers. It is a condition which often occurs from the complications of diabetes and can lead to the need for leg amputation if it isn’t properly treated.
SyberWorks: All right. So what were some of the business reasons that drove your organization to seek out and purchase a learning management system?
Fran: Managing training is our biggest reason for purchasing a learning management system. It was our desire to make the process of getting trained and accessing training materials as easy as possible for our employees.
But more importantly it was the need to be able to manage the training and to assess deficiencies in training and to access training records as easily as possible. That drove our need.
SyberWorks: I know that your industry is highly regulated by the FDA. The FDA can shut a company down if its manufacturing regulations and procedures don't follow their requirements.
Can you explain how this impacts your business requirements in regards to the LMS?
Fran: As an FDA regulated company it is our responsibility to ensure that our employees are properly trained. Therefore it is necessary that we have a reliable and easily assessable database which we use to verify that individuals are properly trained.
SyberWorks: Why did you choose the SyberWorks Learning Management system to manage your training?
Fran: Well, SyberWorks provided me with pretty much all of the options that I needed to maintain and manage the training. It met all my requirements in terms of being able to access the information and to store the information.
I like that it was browser based and I was able to integrate my current SOP processes within it. And also, I think that it is a system that is easy for my users to use.
SyberWorks: Can you give me a brief overview of who will be using the system at your company?
Fran: Basically all our employees use it, because all of them need to be trained and all of them need to have records on their training.
SyberWorks: OK. So it is not just folks on the manufacturing floor where the skin is actually being manufactured?
Fran: No. No. All of our employees need to be trained on all their job duties. So whether they are on the manufacturing floor or just part of customer service, they have a training matrix and they need to follow that training matrix.
SyberWorks: Other than 21 CFR Part 11 Compliance, what are some of the key business systems and requirements that are important to your company’s online training program? Specifically, and you brought it up earlier, how are you using the system to manage your SOP’s and SOP compliance?
Fran: OK. Yes, I did bring it up earlier. All of our employees have a specific job requirement job training matrix that they must follow, so they have specific SOP’s that they must read as a part of that training matrix, and they are required to stay current on those SOP’s. So if an SOP has changed, they need to be notified that the provisions need to be looked at, so I needed a system which would enable them to find out that those SOP's have been revised and then be able to easily go back and train on them.
SyberWorks: OK. Sounds good. How were you able to configure the SyberWorks LMS for 21 CFR Part 11 compliance, i.e. electronic signatures?
Fran: Part 11 compliance was achieved by creating reports that provide audit trails on who and when changes were made to both the user information and training records, and also the ability to provide unique logins and passwords and to ensure good passwords to make the system secure.
SyberWorks: Can you tell us about your personal experience with Syberwork’s brand?
Fran: Well actually I have had great customer support throughout the implementation of the system and currently. Our needs are, I think, unique.
I know there were special things that had to be done for us, so we had a lot of great customer care in helping us fit all our needs into your system.
SyberWorks: Yes. Your SOP process is unique. So you are right about that. Is there anything else you would like to share more about your interaction with SyberWorks before we close up today?
Fran: Only that I am very happy with the purchase. The customer support, like I said, has been great and I have enjoyed working with the people at your company. I am pretty happy about the experience.
SyberWorks: Well terrific. Thanks for joining us today. Everything sounds great. I know you are a busy lady, so I am going to let you go.
Fran: OK. Thank you.
SyberWorks: Thank you for joining us with our interview with Fran Schnack of Advanced Bio Healing on the SyberWorks LMS e-Learning Implementation Interview Series.